2017 SA Grams

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of additional functionality to the eFSAP system.

Beginning December 22, 2017, registered users have the ability to log in and perform the following activities directly in eFSAP:

• Make changes to an entity name or type (Form 1 Section 1a)pdf icon
• Modify an entity’s address (Form 1 Section 1a)pdf icon
• Make changes to the entity abstract (Form 1 Section 1c)
• Add, remove, and edit strains and serotypes of select agents and toxins (Form 1 Section 7b)

Users also now have the ability to directly view or download supporting documents after they have been uploaded into eFSAP. Performance enhancements have also been made to Form 1 Section 4.

Access the system by clicking on the following link and providing your SAMS credentials: https://efsap.selectagents.gov/external icon.

Attached to this message are tutorials with screenshots detailing these new features. In addition, you may contact your FSAP point of contact for assistance with these new features.  If you experience errors or have questions related to the eFSAP system in general or with SAMS access to the system (e.g.,log in problems, system outage) please continue to contact the eFSAP customer support desk using the online help form or through email at eFSAPSupport@cdc.gov, or by phone at (877) 232-3322.   You may also wish to visit our online eFSAP Resource Center.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) would like to correct information sent in an SA Gram dated November 30, 2017.

The SA Gram was sent to alert eFSAP users of a feature in the eFSAP system related to the pending expiration of an entity’s employee’s approval for access to select agents and toxins. In the Section 4 screen of the APHIS/CDC Form 1 found in eFSAP, the system highlights when an individual’s access approval is about to expire:

• When an individual’s access approval is 90 days from termination, their expiration date turns from “blue” to “orange.”
• When an individual’s access approval is 45 days from termination, their expiration date turns to “red.”
• The individual may no longer have access to select agents or toxins once the listed expiration date has passed.

To prevent an individual’s access to select agents and toxins from terminating unnecessarily, we recommend that any individual identified as needing a renewal (90 days from termination or “orange” designation) should email a new FD-961 form to the Criminal Justice Information Services Division (CJIS) at FD961@leo.gov. Please ensure that the photo is scanned according to the digital image requirements on page 4 of the FD-961 and as listed in the instructions for section IV. Fingerprint cards are normally not required – however, CJIS reserves the right to request additional fingerprint cards when they deem it is necessary.

FSAP plans to discontinue sending out “expiring approval” notification letters after December 31, 2017. It is the responsibility of each Responsible Official to monitor the status of their entity’s individuals’ access approvals and ensure that the appropriate renewal paperwork is submitted in a timely manner.

We apologize for any confusion.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has recently posted several new online videos to assist users with completing tasks in the electronic Federal Select Agent Program portal, eFSAP.

The new videos, available here, will help users complete functions associated with APHIS/CDC Form 1 and include the following:

• How to remove personnel (Section 4 amendments)
• How to reactivate personnel (Section 4 amendments)
• How to request a registration renewal

Additional resources will continue to be posted to this page as they become available.

The Federal Select Agent Program (FSAP) would like to remind the regulated community that the select agents and toxins regulations require that a Responsible Official (RO) must have a physical (and not merely a telephonic or audio/visual) presence at his or her registered entity.  The purpose of this regulatory requirement is to ensure that the registered entity is in compliance with the select agents and toxins regulations and that the RO will be able to respond in a timely manner to onsite incidents involving select agents and toxins in accordance with the entity’s incident response plan (See Section 9(a)(5)).  There must be an approved RO or Alternate RO (who has assumed the full RO responsibilities in the absence of the RO) at a registered entity during normal business hours and that individual must be available for emergencies after normal business hours.

In addition, an entity must immediately notify FSAP if the entity loses the services of its Responsible Official (See Section 7(j)).

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has just released a new online resource, the eFSAP Resource Center, dedicated to providing users with everything needed to gain access to and use the new electronic Federal Select Agent Program portal, eFSAP.

At this new section of the FSAP website (available here), users of the new system will find the following types of information:

• A direct link to log on to the eFSAP system.
• What is eFSAP? describes FSAP’s new secure information system, eFSAP, and explains how the system will improve communication between FSAP and regulated entities.
• User Tools provides training materials, reference guides, and answers to frequently asked questions to assist eFSAP users.
• Updates provides the latest information about new features and system roll-out.
• Contact Us if you have any questions or needs regarding eFSAP that are not covered in any of the online resources.

FSAP will be posting regular updates to this page as system features are added and new materials are available.

Currently, the system is being rolled out to users (Responsible Officials and Alternate Responsible Officials) at FSAP-registered entities.  Features related to APHIS/CDC Forms 1-4, personnel amendments, and renewals are now available to those users, with additional functionality soon to come.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) is pleased to announce the deployment of additional functionality to the eFSAP system.

Beginning November 14, 2017, registered users have the ability to log in and perform the following activities directly in eFSAP without the need to submit an amendment or upload any additional documents:

• Generate unique Department of Justice (DOJ) numbers for new laboratory, animal care, and support staff, principal investigators, Alternate Responsible Officials, and owner/controllers
• Update names of entity personnel
• Withdraw personnel from their registration
• Reactivate personnel previously on their registration
• Request registration renewals and electronically sign APHIS/CDC Form 1, section 2

In addition to the current ability to submit an APHIS/CDC Form 3 electronically, effective November 14, 2017, registered users now also have the ability to submit the following electronically:

• APHIS/CDC Form 2
• APHIS/CDC Forms 4A, 4B, and 4C

Enhancements have also been made to notifications and general discussion features, and eFSAP now contains direct links to the eFSAP Help and Support Desk form and email address.

Access the system by clicking on the following link and providing your SAMS credentials: https://efsap.selectagents.gov/external icon.

Attached to this message (available herepdf icon) is a tutorial with screenshots of the new features. In addition, you may contact your FSAP point of contact for assistance with these new features. If you experience errors or have questions related to the eFSAP system in general or with SAMS access to the system (e.g.,log in problems, system outage) please continue to contact the eFSAP customer support desk using the online help form or through email at eFSAPSupport@cdc.gov.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

This is the Federal Select Agent Program (FSAP) response to a question received by the program about whether the regulatory requirement in section 17(a)(8)(vii) of the select agent regulations applies to “routine inactivation of materials being tested at a lower biocontainment level in the same building.”

Section 17(a)(8)(vii) of the select agent regulations requires an entity inactivating a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus to include in its records “[a] certificate, signed by the Principal Investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation or viable select agent removal method used, and the name of the Principal Investigator.” This is generally referred to as an “inactivation certificate.” This section also requires that “[a] copy of the certificate must accompany any transfer of inactivated or select agent removed material.”

For purposes of this requirement, the creation and retention of an “inactivation certificate” is required any time an entity performs an inactivation to exclude a select agent from the requirements of the select agent regulations. For example, see 42 CFR §73.3(d)(4), 7 CFR §331.3 (d)(4), and 9 CFR §121.3(d)(4). The “inactivation certificate” must be maintained by the entity in accord with section 17 (records) even if the inactivated material has left the entity or been subsequently destroyed.

A copy of the certificate must accompany the inactivated material only when the material is transferred externally (entity to entity). However, it is recommended that an inactivation certificate also accompany intra-entity transfers of inactivated material (internally, PI to PI).

You can find the full regulatory interpretation on this topic here.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

Following Office of Management and Budget (OMB) approval, the Federal Select Agent Program (FSAP) has posted updated APHIS/CDC Forms 1-5 to its website (available here) for use by the regulated community.

This includes the updated APHIS/CDC Form 3, which is used by entities to report the theft, loss, or release of a select agent or toxin.  As previously shared, the revised form includes improvements such as clarifying what needs to be reported as a “release” and “loss” and additional fields to assist with categorizing the type of release (e.g., spill within secondary containment, occupational exposure, possible breach of facility containment, etc.), type of exposure, and the understanding of safety and security risk levels relative to human illness.

The update to the APHIS/CDC Form 3 completes a recommendation for program improvementpdf icon and represents significant progress in our efforts to ensure that incident reporting is more informative about the actual and potential risk of reported theft, loss, and release.  Along with the revised APHIS/CDC Form 3, FSAP includes guidance document to assist with completing the form.

No changes were made to the other forms during this process.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has finalized a new guidance document, Guidance on the Transfer of Select Agents and Toxins, to help entities in meeting federal regulatory requirements when transferring or importing a select agent or toxin (7 C.F.R. §331.16, 9 C.F.R. §121.16, and 42 C.F.R. §73.16). The document is now available here.

A draft version of this guidance document was previously shared with the regulated community for review and input prior to being finalized. The final document does not reflect any major changes from the draft version.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

Today, the Federal Select Agent Program published its second annual report of aggregate program data, the 2016 Annual Report of the Federal Select Agent Program.

While similar in content to the information contained in last year’s report, the data provide continued insight into the work conducted with biological select agents and toxins at laboratories across the nation, as well as how the program provides regulation and oversight of these laboratories.  In line with program recommendations received in late 2015, the report reflects FSAP’s ongoing commitment to increasing transparency and understanding of the program.

The full report, along with an infographic and other accompanying background materials, is now available here.

If you have any questions about the report, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or DSATScienceoffice@cdc.gov for CDC/DSAT entities.

On November 28-30, 2017, the Federal Select Agent Program will hold a multi-day in-person workshop for Responsible Officials at the Animal and Plant Health inspection Service headquarters in Riverdale, MD. This year’s workshop will provide participants with information about the new eFSAP information system portal and regulatory requirements for inactivation of select agents and toxins, as well as an opportunity to network with colleagues. A detailed agenda is attached.

The workshop is open to only Responsible Officials or Alternate Responsible Officials and limited to 200 participants. To reserve your spot, please submit your registration herehttps://www.selectagents.gov/registration-ro.htmlexternal icon. Your registration will be confirmed by e-mail.

If you have any questions about the report, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or DSATScienceoffice@cdc.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has finalized updates to its security guidance document,
Security Plan Guidance, which now includes guidance for the security of Tier 1 agents.
Since 2012, Federal regulations have required the implementation of additional security measures for Tier 1 select agents and toxins, including pre-access suitability assessments, extra access controls, and extra barriers. The updated version of the document discusses these requirements in detail.

The document is available here.

A draft version of this guidance document was previously shared with the regulated community for review and input prior to being finalized. The final document does not reflect any major changes from the draft version.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

Recently, the Federal Select Agent Program conducted training for Responsible Officials and Alternate Responsible Officials on our new information system portal, eFSAP, on submitting a request using APHIS/CDC Form 1 (Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins) and APHIS/CDC Form 3 (Report of Theft, Loss or Release of Select Agents or Toxins).  The current release of eFSAP allows ROs and AROs to submit APHIS/CDC Forms 1 and 3 electronically through the new eFSAP information portal.  The current release of eFSAP allows ROs and AROs to submit APHIS/CDC Forms 1 and 3 electronically through the new eFSAP information portal.

The training presentation is available herepdf icon to assist you in this process.

Any access to the system issues encountered may either be reported using a web form or via email at the links below:

Form: https://www.selectagents.gov/efsap/support.htm

Email: eFSAPsupport@cdc.gov

The Federal Select Agent Program (FSAP) will hold a multi-day in-person workshop for Responsible Officials (ROs) and Alternate Responsible Officials (AROs) from November 28-30, 2017 in Riverdale, MD, at the Animal and Plant Health Inspection Service headquarters: 4700 River Road, Riverdale, MD 20737. Sessions will take place each day from 8 a.m. to 4 p.m. EST.

This year’s workshop will provide participants with information about the new eFSAP information system portal, regulatory requirements for inactivation of select agents and toxins, and maintaining select agent regulatory compliance, as well as an opportunity to network with colleagues.

Please save the date. More information will be forthcoming in the next few weeks, including a detailed agenda and registration instructions. Registration is open to Responsible Officials and Alternate Responsible Officials only.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

Based upon consultations with subject matter experts and a review of relevant published studies and information provided by the entities requesting the exclusions, the Federal Select Agent Program has determined that the following attenuated strains are not subject to the requirements of the select agent regulations:

• Burkholderia pseudomallei strain 576mn (effective August 18, 2017)
• Yersinia pestis CO92 triple mutant ΔlppΔmsbBΔail (effective May 19, 2016)

Additional information regarding the excluded strains can be found at https://www.selectagents.gov/sat/exclusions/index.htm.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has finalized its severity spectrum of inspection departures and enforcement options; this spreadsheet outlines categories of inspection regulatory departures grouped according to the level of severity, as well as related enforcement options that may be applied. The document, posted online and now available here, aims to provide awareness of how FSAP considers the severity of inspection findings and provide visibility to the application of enforcement options to these findings. Example violations are grouped into a three-tier risk scoring system in the categories of low, moderate, and serious severity levels.

Departures may include findings of low risk as well as findings that may lead to an immediate stoppage of some or all activities. Please note that this is not meant to be an all-inclusive list of possible departures, but is meant to convey, at a large scale, how FSAP views risk.

As you may recall, the draft document was previously shared with the regulated community for review and input prior to being finalized. While the final document incorporates feedback received to date, it does not reflect any major changes from the draft version.

The document was developed as a part of FSAP’s efforts to increase the quality and consistency of inspections and addresses a number of program improvement recommendations received as part of the CDC 90-day Reviewpdf icon and the Fast Track Action Committee on the Select Agent Regulationspdf iconexternal icon. Completion of this item reflects another important milestone for the program in meeting those recommendations.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has issued a final policy statement regarding the approval of a person to be a Responsible Official (RO) at only one entity.

It is the policy of the FSAP that:

• An individual will not be approved by the FSAP to be an RO at more than one entity.
• An individual who has been approved to be an RO will not be approved by the FSAP to be an Alternate Responsible Official (ARO) at another registered entity.
• An individual who has been approved by the FSAP to be an ARO at one entity can be approved by the FSAP to be an ARO at another registered entity as long as when they serve as RO, they can meet the provisions outlined in Section 9 of the select agent regulations.

This policy is posted here.

A draft of this policy was previously shared with the regulated community for feedback. As a result of feedback received during this period, revisions were made to address the ability for a single individual to be approved as an ARO at multiple entities.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has issued a policy statement regarding the non-exclusion of study-related activities involving naturally infected animals from the requirements of the select agent regulations.Per the select agent regulations, possession of an animal which is naturally infected with a select agent, either within its natural environment or having been transported to an artificially established environment, meets the regulatory exclusion criteria.  [See 42 C.F.R. §§73.3(d)(1), §73.4(d)(1); 9 C.F.R. §§121.3(d)(1), 121.4(d)(1)]

However, it is the policy of the Federal Select Agent Program that

• removal of an animal which is naturally infected with a select agent from its natural environment to an artificially established environment for the purpose of the intentional exposure or introduction of a select agent to a naïve or experimental animal, or
• the introduction of a naïve animal to a natural environment where there is an animal which is naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to the naïve or experimental animal

does not meet the regulatory exclusion criteria. Accordingly, any work with an animal naturally infected with a select agent for the purpose of the intentional exposure or introduction of a select agent to any naïve or experimental animal may only be conducted after FSAP approval for an entity or individual registered for possession and use of such select agent.

If an animal is confirmed to be naturally infected with a select agent there may be additional transfer and/or transport restrictions based upon specific USDA and state requirements.

This policy is posted here.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) wishes to provide the following information to the regulated community to assist with the implementation of the specific requirements related to information provision and documentation as outlined in Section 9(a)(7) and Section 15(e) of the select agent regulations.

Specifically:

• Section 9(a)(7) – The RO must ensure that as of March 21, 2017, all individuals listed on the entity’s registration have been provided the contact information for the HHS Office of Inspector General Hotline and the USDA Office of Inspector General Hotline so that they may anonymously report any biosafety or security concerns related to select agents and toxins); and
• Section 15(e) – The RO document that individuals have been provided the above referenced information.

We note that the regulatory requirements found in sections 9(a)(7) and 15(e) of the select agent regulations are not an “annual training” requirement; but rather, an “ongoing” requirement.

We also note that a registered entity has a great deal of flexibility in how it meets these requirements. It may post the information where everyone associated with the registered entity has ready access to the information. It may individually inform each person associated with the registered entity; but if it takes that approach, the entity must ensure that each new person also receives the information. As for documentation, a registered entity may either do so by posting the information or creating some type of record describing the method the entity uses to ensure that individuals are provided the contact information.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has issued a revised policy statement regarding the inactivation of Bacillus anthracis, including Bacillus anthracis Pasteur strain and Bacillus cereus Biovar anthracis. Key changes are as follows:

1. Clarifies that the policy includes exclusion for certain inactivated material
2. Removes the kill curve and neutralization curve requirements
3. Clarifies other language throughout (non-substantive changes)

The revised policy replaces the previous FSAP policy statement on the subject (issued April 19, 2017). All elements of the revised policy take effect immediately.

The policy is available here.

The corresponding frequently asked questions have also been updated, and are available here.

The Federal Select Agent Program (FSAP) wishes to remind the regulated community that the requirement to validate inactivation procedures applies to formalin fixation of tissues. Entities must validate the formalin fixation procedure by performing a viability test in-house.

Please refer to the FSAP policy dated April 6, 2017 for more information on in-house validation. The policy is available at here. For your reference, the latest FSAP guidance document on inactivation is also available at here.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or DSATScienceoffice@cdc.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) wishes to share the following information for your awareness.

The Centers for Disease Control and Prevention recently published a notice in the Federal Registerexternal icon on August 3, 2017 seeking public comment on the revised APHIS/CDC Form 3, which is used by entities to report theft, loss, or release of a select agent or toxin. The Federal Select Agent Program (FSAP) revised the APHIS/CDC Form 3 to further clarify what needs to be reported as a “release” and “loss” and included additional fields to assist with categorizing the type of release (e.g., spill within secondary containment, release due to failure of inactivation, occupational exposure, possible breach of facility containment, etc.), type of exposure, and the understanding of safety and security risk levels relative to human illness.

Efforts to update the APHIS/CDC Form 3 follow recent recommendations for program improvements, and you may recall that earlier versions of this revised document have been previously shared by FSAP for feedback, as well as updated accordingly. The notice also acknowledges that FSAP has updated its series of guidance documents.

To request additional information on the revised APHIS/CDC Form 3 or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or suggestions on the APHIS/CDC Form 3 should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments must be received on or before September 2, 2017.

As a part of the Federal Select Agent Program (FSAP)’s efforts to increase the quality and consistency of inspections, as well as the content and clarity of inspection reports, in October 2016 the Centers for Disease Control and Prevention (CDC)’s Division of Select Agent and Toxins (DSAT) began a pilot project for issuing inspection summaries (“report cards”) to DSAT-registered entities. These report cards were issued along with the inspection report to summarize the entity’s regulatory departures following an inspection and show how its performance compares relative to other entities.

After a pilot period, during which approximately 50 report cards were issued, DSAT has concluded the pilot and will not be issuing any further inspection report cards in the immediate future. During this intermission, DSAT will work to adjust the model used to develop these report cards to better incorporate and reflect recent changes to the regulations following the March implementation of the amended select agent regulations. The program will also make any additional needed adjustments, including changes that may need to be made as a result of implementation of the new FSAP IT system (eFSAP).

Following this evaluation period, DSAT intends to resume issuing inspection report cards as a routine part of inspection reports. We will continue to keep you updated.

If you have any questions, please contact CDC’s Division of Select Agents and Toxins at lrsat@cdc.gov or 404-718-2000.

The Federal Select Agent Program (FSAP) recently conducted Secure Asset Management System (SAMS) enrollment training as part of the transition to FSAP’s new secure information system, eFSAP. SAMS enrollment is required to access the eFSAP information system. Many ROs and AROs have already received an automated invitation directly from SAMS to initiate enrollment; those who have not yet received an invitation will receive one shortly.

We have received a number of questions about SAMS and the upcoming transition to eFSAP. Please see the information below and attached pdf icon[PDF – 26 KB] to assist you with enrollment questions and to provide additional information about eFSAP.

A few of our most frequently asked questions are as follows:

1. I have not yet received my SAMS invitation email. Was I overlooked?
   We are still issuing SAMS invitations for ROs and AROs who did not attend SAMS training. We have issued invitations to all SAMS training participants. If you attended any of our training sessions but did not yet receive your invitation, please look first in your spam folder, then contact us at DSATSAMSHELP@cdc.gov for another invitation to be sent to you.
2. I have completed the SAMS enrollment process. When I click on the SAMS link, I get an error message. What am I doing wrong?
   You will receive an error message when you attempt to access the system until we activate the system for you. The initial step for you to gain access to eFSAP was enrollment in the SAMS system. We will notify you when you are able to view your data. We will also provide additional training for you on the eFSAP system and communicating with FSAP through the portal prior to our launch date.
3. Our ROs and AROs share a corporate email box. Will this be an issue when we try to enroll in SAMS?
   Yes, each SAMS user must have a unique email address associated with your account. You may use the shared email address but it will only be associated with one specific person.
4. I did not finish the enrollment process within 30 days as required. What do I need to do?
   Once you receive your invitation to enroll in SAMS, you must complete the enrollment process within 30 days. We will send you a reminder email prior to your invitation expiring, but after 30 days you must contact DSATSAMSHELP@cdc.gov for another invitation to be issued.

Additional notes:

• CDC-led entities are requested to use the DSATOps@cdc.gov mailbox for submission of all amendments and inspection-related documents.
• APHIS-led entities should continue to use the AgSAS@usda.gov mailbox for submission of amendments and inspection-related documents.
• Entities adding personnel to the entity registration must submit applications for security risk assessment (FD-961) directly to the Criminal Justice Information Service (CJIS) in order to expedite the amendment approval process. Applications should be submitted to:
  • FBI, CJIS, Bioterrorism
    1000 Custer Hollow Road, Module E-3
    Clarksburg, WV 26306-0147

For guidance on how to complete the FD-961 form, please see the FBI websiteexternal icon for additional information.

We hope that this additional information is helpful to you. If you have further questions, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

On April 28, 2017, the Federal Select Agent Program (FSAP) hosted a webcast to provide specific regulatory guidance and information on changes to the select agent regulations and on standards concerning biosafety, security, and incident response.  The Federal Register notice, workshop agenda, presentations, a recording of the webcast, and responses to questions received during the webcast are now posted on the FSAP website at https://www.selectagents.gov/resources/training.htm.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation regarding a select agent or toxin that has been subjected to decontamination or a destruction procedure when intended for waste disposal.

The questions and answers are as follows:

• Does waste containing select agents or toxins decontaminated with commercial products (i.e. phenol, chloroform, phenol/chloroform, or Trizol™ or other similar commercial product waste) meet the exclusion provisions outlined in sections 3(d)(3) and 4 (d)(3) of the select agent regulations? Yes. For chemical decontamination, the chemical used must be appropriate for the select agent or toxin (Manufacturers normally test surrogates and not select agents and toxins. This would be acceptable.), and the chemical concentration and contact time should be defined in the procedure. The procedure should also address whether chemicals used for decontamination must be freshly prepared or can be stored, and note the shelf life if stored.
• Is waste containing select agents or toxins decontaminated with commercial products (i.e. phenol, chloroform, phenol/chloroform, or Trizol™ or other similar commercial product waste) allowed to be moved to off-site for disposal by incineration as chemical waste, using an Environmental Protection Agency-registered hazardous waste contractor?
  Yes. The decontaminated waste would be considered excluded from the select agent regulations as outlined in sections 3(d)(3) and 4 (d)(3) of the select agent regulations.  You can find the full regulatory interpretation on this topic here.If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

Today, the Federal Select Agent Program (FSAP) released an updated version of its inactivation guidance document, Guidance on the Inactivation or Removal of Select Agents and Toxins for Future Use.

Changes have been made throughout the document for clarity and to update the recordkeeping section of the document to reflect the recent FSAP regulatory interpretation regarding the inactivation certificates as it relates to external and intra-entity transfers.

This and other FSAP guidance documents are living documents, which we will continue to update and refine over time.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or DSATScienceoffice@cdc.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) is transitioning to a new secure information system that will contain select agent program information from all registered entities.  When completed, all registered entities will be able to review/print their current registration, submit all amendments, submit supporting documentation, and communicate with FSAP via the electronic portal.

The FSAP is pleased to announce that it has begun the process of migrating all current APHIS/CDC Form 1 information into the new secure information system.  Soon, the FSAP will be issuing Secure Access Management Services (SAMS) account invitations to all Responsible and Alternate Responsible Officials currently registered with the FSAP so that they may access their select agent and toxin information in the new system and directly manage their registration information.  FSAP expects initial release of the new database system to all entities by late summer.

The FSAP is committed to ensuring that new APHIS/CDC Form 1 amendments and updates to any pending amendments continue to be accepted and processed during the migration of existing entity data.  In order to ensure continuity of operations during the data migration, effective Monday, June 26, submission of all APHIS/CDC Form 1 documents should proceed as follows:

1. For submission by email, entities registered with the Centers for Disease Control and Prevention, Division of Select Agents and Toxins, should use the following email address:  dsatops@cdc.gov.  Entities registered with the Animal and Plant Health Inspection Service, Agriculture Select Agent Services should use the following email address:  AgSAS@usda.gov.  Please do NOT send documents to your file manager’s email account.  Begin the subject line of the email with the name of your entity exactly as indicated on section 1 of your latest approved APHIS/CDC Form 1.
2. For submission by facsimile, entities registered with the Centers for Disease Control and Prevention, Division of Select Agents and Toxins, should use fax number 404-471-8425.  Please do NOT use 404-718-2096.  Entities registered with the Animal and Plant Health Inspection Service, Agriculture Select Agent Services should use the following fax number 301-734-3652.  You must include your entity’s name in the fax cover sheet or cover letter accompanying your submission.

All entities should continue to submit all other FSAP documents – APHIS/CDC Form 2 (“Request to Transfer Select Agents and Toxins”); APHIS/CDC Form 3 (“Report of Theft, Loss, or Release of Select Agents and Toxins”); and APHIS/CDC Form 4 (“Report of the Identification of a Select Agent or Toxin”) – in the same manner as you have done in the past.  For questions and general correspondence, continue to use your file manager’s email account or telephone number.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

In response to a recent request, the Federal Select Agent Program has posted to its website a regulatory interpretation regarding whether there is a requirement for a copy of an inactivation certificate signed by a Principal Investigator (PI) to accompany “routine inactivation of materials being tested at a lower biocontainment level in the same building.”

The inactivation certificate is only required when the material is transferred externally (entity to entity). It is recommended that an inactivation certificate accompanies intra-entity transfers of inactivated material internally (PI to PI). Additionally, regardless of the type of subsequent transfer, an entity remains responsible for the recordkeeping requirements found in section 17(a)(8) of the select agent and toxin regulations.

Separately, the interpretation also notes that a contractor can be designated as a PI.

You can find the full regulatory interpretation on this topic here.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or lrsat@cdc.gov for CDC/DSAT entities.

On February 18, 2017, the OIE (World Organisation for Animal Health) reported samples obtained from live bird markets in China, sent to the National Reference Laboratory for Avian Influenza by the Guangdong veterinary authorities, tested positive for H7N9 highly pathogenic avian influenza virus (HPAIV). Retrospectively, samples were identified as H7N9 HPAIV in Guangdong extending back to as early as October 2016. This Asian lineage H7N9 HPAIV is not related to the recent finding of North American wild bird lineage H7N9 HPAIV in United States (US) poultry during March 2017.

The Asian H7N9 lineage was first reported in February 2013 as a low pathogenic avian influenza virus (LPAIV) which continues to circulate primarily in live bird markets in China, and causes human morbidity and mortality. As of April 2017, the Asian lineage H7N9 HPAIV has been isolated from poultry, the environment, and from people (http://www.fao.org/ag/againfo/programmes/en/empres/h7n9/situation_update.htmlexternal icon).

In light of these recent findings, additional supporting information will now be required for facilities requesting Asian lineage H7N9 strains in order to differentiate LPAIV from HPAIV. HPAIV is a USDA VS Select Agent, and may only be possessed, used or transferred in the United States by entities registered with the Federal Select Agent Program.

In general, any request to receive low pathogenicity avian influenza A viruses for import and/or interstate transportation requires a VS 16-6 permit from the National Import Export Service (NIES), Organisms and Vectors (OV) Unitexternal icon. This permit can be requested via the VS 16-3 permit application.

As of the date of this notice, facilities requesting to receive Asian lineage H7N9 LPAIV will also be required to obtain a letter of exclusion at the time of the VS 16-3 permit application submission, which indicates that the material requested demonstrates a low pathogenicity phenotype. To obtain a letter of exclusion, provide either A) HA-gene sequence data consistent with H7N9 LPAIV genotype, and in vivo testing per OIE indicating a low pathogenic phenotype (either intravenous pathogenicity index [IVPI] of <1.2, or chicken lethality assay), or B) next generation full genome sequence data with depth of coverage >1000-fold to aid in excluding the potential of co-infection/ contamination with a high pathogenicity genotype, and duplicate plaque characterization testing using chicken embryo fibroblast cells (or other suitable cell line) with and without trypsin. Data should be sent to AgSAS@usda.gov.

A facility requesting to receive Asian lineage H7N9 LPAIV will also be required to request a letter of exclusion from APHIS (indicating that the material requested demonstrates a low pathogenicity phenotype) at the time of the VS 16-6 permit application submission.

Permit application requests to Centers for Disease Control (CDC) for the importation of Asian lineage H7N9 strains will be held by CDC until an approved APHIS VS 16-6 permit is submitted to the CDC Import Permit program as supporting documentation.

Movement of all other HPAI material requires an APHIS/CDC Form 2 “Request to Transfer Select Agents and Toxins”.

Additional information related to avian influenza viruses can be found herepdf icon.

If you have any questions regarding this notice, please contact the Federal Select Agent Program at 301-851-2070 (8:00 am to 4:30 pm Eastern) or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

[1] There are molecular and biologic criteria, specific to chickens, which define an avian influenza virus as either low or high pathogenicity. Such criteria do not address infectivity nor pathogenicity in humans.

Today, CDC’s Division of Select Agents and Toxins (DSAT) has published its second annual analysis of inspection report timeliness, the 2016 DSAT Inspection Report Processing Annual Summary.

Inspection reports play a critical role in ensuring the safety and security of work with select agents and toxins.  These reports contain findings from inspections conducted by the Federal Select Agent Program (FSAP) and detail any corrective actions needed – therefore, timely issuance allows entities to take action and promptly address any concerns.

The new report (available herepdf icon) analyzes inspection report timeliness throughout 2016, examining the length of time required to issue a report following an inspection (for both final reports and new interim reports), as well as associated variables.  For those reports with delays, the analysis also looks at the reason for those delays.

This second annual report comes as a result of program improvement recommendations made to DSAT in late 2015.  All DSAT-led inspections conducted as part of FSAP, including joint inspections with colleagues at the Agriculture Select Agent Services, are included in the data.

Key findings include:

• DSAT made substantial improvements in its ability to provide timely feedback to entities — through the introduction of new interim reports as well as by reaffirming its commitment to issuing final reports within 30 days after an inspection.
• Improvements in report timeliness occurred across all inspection types where there was room for improvement.
• Inspection type is a reliable predictor of report timeliness, with complex maximum containment inspections taking the longest to complete.

The findings also underscore the importance of routine analyses of reasons for any delays, because the earlier these issues can be identified, the quicker they can be addressed to prevent reoccurring concerns.

These substantial improvements in timeliness reflect DSAT’s commitment to improving the program over the past year, and the publication of today’s report represents our continued pledge to increase transparency and understanding of the program.  However, despite the signs of progress detailed in this report, our work here is not done – we will continue to work towards further improvement.

If you have any questions about the report, please contact DSAT at 404-718-2000 or DSATScienceoffice@cdc.gov.

Today, the Federal Select Agent Program (FSAP) has released an updated version of its select toxin guidance document.  The document is available here and includes updates to the section regarding the reporting requirements for identification of a select toxin (APHIS/CDC Form 4).  The updates clarify the circumstances in which original food and clinical samples are excluded from the requirements of the regulations.

This and other FSAP guidance documents are living documents, which we will continue to update and refine over time.

If you have any questions regarding this email, please contact 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or DSATScienceoffice@cdc.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has posted a new template online (available here) to assist entities in developing biosafety/biocontainment plans that meet the requirements found in section 12 of the select agent regulations.  The template is customizable to fit the specific needs of the entity.

This document is provided as a resource. FSAP does not require use of this specific template.

A previous version of the template was shared with the regulated community for feedback.  In the process of finalizing the document, information on occupational health programs has now been incorporated into this template.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.

The Federal Select Agent Program (FSAP) has developed a policy statement to clarify new regulatory requirements for the inactivation of select agents which call for the Responsible Official (RO) to “investigate to determine the reason for any failure of a validated inactivation procedure or any failure to remove viable select agent from material.” The regulations state that if the RO is “unable to determine the cause of a deviation from a validated inactivation procedure or a viable select agent removal method; or receives a report of any inactivation failure after the movement of material to another location, the Responsible Official must report immediately by telephone or email the inactivation or viable agent removal method failure to CDC or APHIS.” See 42 C.F.R. § 73.9(a)(8), 9 C.F.R. § 121.9(a)(8), 7 C.F.R. §331.9(a)(8).

It was and is the intent of the FSAP that the use of the phrase “a deviation from a validated inactivation procedure or a viable select agent removal method” means “a failure of a validated inactivation procedure or a viable select agent removal method.”

This policy is posted here.

If you have any questions regarding this email, please contact the Federal Select Agent Program at 301-851-2070 or AgSAS@usda.gov for APHIS/AgSAS entities, and 404-718-2000 or LRSAT@CDC.gov for CDC/DSAT entities.